Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain (TD-RCT-002)

Baylis Medical

Status and phase

Terminated

Phase 4

Conditions

Low Back Pain

Treatments

Device: Sham biacuplasty

Device: Disc biacuplasty

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00749554

TD-RCT-Burnham

Details and patient eligibility

About

The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18 years
Able to understand the informed consent and baseline/follow-up questionnaires
Chronic low back pain > leg pain for longer than 6 months, unresponsive to comprehensive non-operative treatment
No clinical evidence of SI joint mediated pain
Concordant pain reproduced on provocative discography at an intensity of >6/10 at low pressure (<50 psi) at not more than 2 discs and a negative response at an adjacent control disc
Preservation of at least 50% height of the symptomatic disc(s)

Exclusion criteria

Active radicular pain
Nucleus pulposus herniation > 5 mm, extrusion or sequestration on MRI
Spondylolithesis at the symptomatic level
Prior surgery at the symptomatic level
Concomitant cervical or thoracic pain >2/10 (VAS) in severity
Other chronic pain conditions (i.e. Fibromyalgia Syndrome)
Immunosuppression (i.e. Cancer, AIDS, Rheumatoid arthritis)
Third-party (WSIB, litigation or insurance) involvement
Psychological issues impeding recovery by history, examination and/or a Beck Depression Inventory score of >20
Systemic or localized infection (at the anticipated needle entry sites)
BMI > 35 (Obesity)
Substance or opioid abuse
Coagulopathy